For further information about the VIS process, please contact VIS@gavi.org.
Beginning with the first successful vaccine against smallpox in 1796, to the latest vaccines against pathogens such as COVID-19 and malaria, new vaccines are continually being developed, tested and rolled out to save lives. Every five years, Gavi takes stock of the vaccine landscape to assess the impact, cost, value and programmatic feasibility of underused or new vaccines of highest relevance to Gavi-eligible countries via the Vaccine Investment Strategy (VIS). The VIS sets new priorities for Gavi’s vaccine support programmes in a transparent manner through in-depth, evidence-based analysis and extensive consultations, including with independent experts.
Led by Gavi’s Policy team, the VIS process has helped increase Gavi’s portfolio from vaccines against 4 infectious diseases in 2000 to 19 today – including Board approvals for Ebola vaccine in 2019, COVID-19 vaccine in 2021 and malaria vaccine in 2022.
Gavi’s disease prevention focus and vaccine portfolio have evolved over time, moving from vaccines focused on routine infant immunisation to prevent endemic disease to include vaccines that target other age groups, such as HPV, as well as vaccines that support outbreak, epidemic and pandemic preparedness and response (PPR) through the establishment of global stockpiles.
The VIS operates on a five-year cycle to provide Gavi implementing countries, manufacturers, donors and other partners with predictability and information to support long-term strategic planning of immunisation programmes, as well as our upcoming strategic period. The process is focused on the needs and priorities of lower-income countries. The five-year time span reflects the long lead time required to develop; demonstrate technical success and model impact of; and approve vaccines.
Each VIS process has been tailored to reflect the current global context and Alliance strategic priorities, as well as the availability of data and improved methods for assessing impact. VIS 2024 will be no exception – aligning with Gavi’s strategic priorities and considering innovative vaccine technology; a post-pandemic environment; impact of climate change; human-animal interface; as well as demographic transition, urbanisation and rise of antimicrobial resistance (AMR).
In late 2022, Gavi initiated the planning for VIS 2024; in June 2024, the Gavi Board will take a final decision to inform Gavi investments between 2026–2030. The VIS process is overseen by Gavi’s governance structures: the Programme and Policy Committee (PPC) reviews, monitors and makes recommendations to the Gavi Board, which then makes the final decisions on VIS investments.
The assessment and evaluation of vaccine candidates is completed in three phases and Board decisions:
First Board decision: approval of longlist and evaluation frameworks.
Second Board decision: approval of shortlist of vaccines to be developed into investment cases.
Third Board decision: final decision on investment cases
The VIS process begins with an analysis of the vaccine landscape carried out by the World Health Organization (WHO) using the following inclusion criteria:
VIS 2024 is in close alignment with the development of the Gavi 6.0 strategy to ensure that the outcomes of VIS 2024 respond to and inform the strategic priorities defined in Gavi 6.0, which is scheduled for Board review in June 2024.
VIS analyses are based on evidence and data that together provide an understanding of the full value of vaccines, beyond their impact on mortality and morbidity – to include social, economic and population health benefits. Our analyses help: inform the evaluation of pipeline vaccines and vaccines not currently in Gavi’s portfolio; determine the most relevant investment type; and understand potential designs for learning agendas and further data collection.
VIS analyses review the burden of disease and identify the most appropriate vaccination strategy for Gavi-eligible countries to enable demand forecasting. These data inputs are used to model health impact and costs, while implementation feasibility is also considered. Finally, vaccine candidates are compared to one another across these different factors, and to the current portfolio, to arrive at investment decisions. The VIS is highly consultative and inclusive, drawing on the breadth of multidisciplinary expertise of Alliance partners and other stakeholders – including countries, donors, civil society organisations (CSOs), disease experts and modelers – to reflect diverse perspectives.
These analyses are structured around an evaluation framework that is developed for each VIS. The framework reflects Gavi’s core mission (i.e. save lives and protect people’s health), Alliance stakeholder strategic priorities, as well as a review of the previous evaluation approach for continued fit and relevance. In addition, analyses are conducted on specific topics to identify opportunities and perspectives on additional measures of value and impact. The framework includes criteria and indicators that can be quantitative or qualitative and that are weighted differently to inform the prioritisation process.
The data we use to analyse vaccine products is highlighted below. VIS data requirements align closely with those outlined in the WHO Full Value of Vaccines Assessments (FVVA), as well as the Evidence Considerations for Vaccine Policy Development (ECVP).
The VIS has two evaluation frameworks: one for endemic diseases and one for epidemic diseases. The public health goal of Gavi’s potential vaccine investment informs the evaluation framework that is used.
While the VIS process includes products for outbreak, epidemic and pandemic preparedness and response (PPR), these can also be evaluated in real-time when needed to facilitate agile decision-making in context of a public health event or R&D milestone. The epidemics process in based on:
The VIS Steering Committee is convened prior to each PPC meeting (i.e. December 2022, March 2023, September 2023, March 2024) to deliver independent expert advice to the Gavi Secretariat across multiple perspectives. As per the Terms of Reference, the VIS Steering Committee will:
The VIS Steering Committee is comprised of 20 individuals, including a Chair with strong technical and/or scientific expertise and broad-ranging perspectives on aspects pertinent to VIS analyses and decisions. Type of expertise includes, but is not limited to, epidemiology, health impact analysis/modelling, economic evaluations, vaccine implementation and service delivery, research and development, and health financing and planning. Members have been either: selected based on their individual expertise from a pool of applicants to an open call for expressions of interest; or appointed by the Secretariat ex officio to represent partner institutions and stakeholders – including two members of Gavi’s PPC (to serve as liaisons, providing strategic guidance and ensuring alignment between the committees); and a civil society organisation (CSO) representative.
LIST OF VIS 2024 STEERING COMMITTEE MEMBERS
|Helen Rees, Chair
Universidad Nacional Autónoma de México
Imperial College London
London School of Hygiene & Tropical Medicine
Johns Hopkins Bloomberg School of Public Health
University of Washington, Seattle
University of Zimbabwe College of Health Sciences
The Carter Center Sudan
Developing Countries Vaccine Manufacturers Network
KEMRI - Wellcome Trust Research Programme
Ministry of Health Ethiopia
In December 2020, due to the COVID-19 pandemic, the Gavi Board paused or delayed availability of funding for vaccines that had been approved for inclusion in the 2021–2025 strategic period as part of the previous VIS (VIS 2018): rabies; hepatitis B birth dose; diphtheria, tetanus and pertussis (DTP)-containing boosters; and respiratory syncytial virus (RSV).
In 2023, the Gavi Secretariat will present the PPC with the following options for their consideration:
Investment cases for VIS 2018 vaccines: